Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: oxygen therapy; Device: niv plus oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02012101

2009CB522111

Details and patient eligibility

About

The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.

Full description

Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients. However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.

Enrollment: 18 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
• stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
• dyspnea as a main symptom that limited daily activities

Exclusion criteria

• obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
• facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
• oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
• systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
• unstable angina or a myocardial infarct in the previous four weeks
• resting sinus tachycardia ( > 120 beats/min)
• patients with musculoskeletal or neurological disorders
• patients who are unable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

niv plus oxygen therapy

Experimental group

Description:

oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point

Treatment:

Device: niv plus oxygen therapy

oxygen therapy

Active Comparator group

Description:

oxygen therapy is given during the whole experimental process

Treatment:

Device: oxygen therapy